Good morning and thank you Peter (Peter Hutt of Covington and Burling, CRN Outside Counsel) for your kind introduction.

I'd also like to thank Byron Johnson (Chairman of CRN) and most especially Dr. Annette Dickinson, (President of CRN) whom I understand is going to retire after 30 years with CRN, for the many ways in which CRN, under their guidance, has supported FDA's activities in food safety and nutrition.

I especially commend the Council for Responsible Nutrition, as a leader in the dietary supplement industry, for their support both of FDA's enforcement activities to protect the consumer from unsafe dietary supplements, and our efforts to empower consumers to make better health choices by providing better information on food and supplement labels.

It's a pleasure and an honor to speak to you this morning on where FDA stands today with respect to ensuring full implementation of the Dietary Supplement Health and Education Act (DSHEA). But first, I want to update you on some of the ways that we as an agency are pursuing our goals of protecting American consumers from products with false or misleading claims or containing unsafe ingredients, and empowering consumers with the knowledge to improve their own health through informed dietary choices.

In September 2004 we released a report that outlines our progress towards the priorities that I laid out in my August 2 address at the National Press Club. Let me highlight just a few of the accomplishments and top priorities that relate to CRN members as producers and distributors of dietary supplements.

Two very important priorities described in the report are: Using risk-based management practices in our compliance and enforcement activities; and empowering consumers to achieve better health by providing better information on products that FDA regulates.

As part of achieving our goal of using risk-based management practices, one of our highest priorities is to revamp all our guidance and regulations on current good manufacturing practices (cGMPs). This includes existing pharmaceutical and food GMPs and development of dietary supplement GMPs. I'm pleased to tell you that we have succeeded in publishing draft and final guidance relative to pharmaceutical GMPs; we published a report and held public meetings on revamping the food GMPs; and, in March 2003 we published advanced notice of public rule-making on dietary supplement GMPs. We will also employ operational risk management strategies in monitoring the safety of dietary supplements.

We have also made tremendous progress towards our goal of empowering consumers with accurate information to improve their health. For instance, we published a regulation that will require that labels disclose the amount of trans fatty acids in foods and certain dietary supplements. In addition, under provisions of the Nutrition Labeling and Education Act of 1990, we allow food labels, including dietary supplement labels to carry unqualified claims about certain relationships between a dietary substance and a disease or health-related condition when the relationship is supported by significant scientific agreement.

However, we also believe that consumers should get more timely access to important information about nutrition and disease risk-reduction at earlier stages of scientific knowledge as long as that information is truthful and not misleading. Claims based on such knowledge should be clearly qualified so that consumers understand that they are not supported by significant scientific agreement. So, in 2003, FDA published interim guidance on a rating system to characterize the strength of the scientific evidence that supports purported nutrient-disease relationships.

In another interim guidance, we set out a process for FDA review of petitions for claims regarding proposed dietary substance-disease relationships and how we believe manufacturers can communicate these qualified claims in a non-misleading way. We are currently conducting and analyzing research to determine the utility of such communication.

I'd like to focus now on an issue that I'm sure is near and dear to the hearts of CRN members, and that is FDA's progress with the Dietary Supplements Health and Education Act. This Administration has shown an unprecedented commitment to its full implementation and success, and that's why I'm pleased to announce additional steps and priorities we intend to accomplish this calendar year.

I know that you in the dietary supplement manufacturing industry are aware that FDA has been aggressively pursuing the development of an overall strategy to implement DSHEA that would provide clear guidance to the industry on what is and is not acceptable, and so I am especially pleased to be with you for your annual conference today and announce FDA's forthcoming umbrella strategy for the further implementation of DSHEA. There will be a number of documents and a guidance that we expect to publish in the next few weeks, which will outline in detail our comprehensive implementation strategy.

We are providing this information to the industry to promote transparency, consistency and predictability concerning FDA regulation of dietary supplement products and ingredients. Our goal, of course, is to protect consumers against unsafe dietary supplements and dietary supplements with unauthorized, false or misleading claims.

Our overall strategy for further implementation of DSHEA will consist of three major initiatives: monitoring and evaluation of product and ingredient safety; assurance of product quality; and monitoring and evaluation of product labeling.

This forthcoming strategy will refine and clarify the direction the agency is taking to regulate dietary supplements. With this strategy, we will now have a clear roadmap to share with the dietary supplement industry, and at the same time give consumers a higher level of assurance about the safety of dietary supplement products and the truthfulness of their labeling.

This strategy will set forth a series of specific, integrated research and regulatory measures, including guidance, regulations, and science-based compliance and enforcement mechanisms. Our hope is that the improved transparency will help engage stakeholders in the development of further measures to implement DSHEA.

Many of you in this room represent dietary supplement manufacturers, and you know that under DSHEA it is you who are responsible for assuring that the products you produce and distribute are safe. Your products do not need approval from FDA before they are marketed, although in the case of some new dietary ingredients, the law does require pre-market review for safety and other information.

Just to remind you, DSHEA does require dietary supplement manufacturers to submit a premarket safety notification for certain new dietary ingredients. For these ingredients, there must exist evidence that establishes a reasonable expectation of safety and firms must notify FDA at least 75 days prior to marketing.

Manufacturers do not need to register their dietary supplement products with FDA before producing or selling them. Furthermore, there are currently no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

The manufacturer is also responsible for assuring that any representations or claims made about their dietary supplements are substantiated by adequate evidence to show that they are not false or misleading. In fact as one of our most recent steps towards full implementation, FDA has just sent out letters to dietary supplement manufacturers and to distributors, reminding them of their responsibilities under DSHEA regarding label claims, the focus of these letters was on dietary supplements to promote weight loss.

One of the initiatives under our new umbrella strategy is intended to result in clarification of when a dietary ingredient is a "new dietary ingredient" for which notification is required and what safety information should be sent to FDA before marketing of the product.

On October 20 th, just five days ago, we published a Federal Register notice announcing a public meeting to be held at FDA's Center for Food Safety and Applied Nutrition offices in College Park on November 15, 2004. The purpose of this meeting is to solicit comments from stakeholders on the content and format requirements for NDI notification.

Specifically, we are seeking your input on what should be considered in determining the status of an ingredient as an NDI; what should be included in the chemical identification of the NDI; what information is needed about the dietary supplement containing the NDI; and, how a reasonable expectation of safety of the NDI should be established. Following the review of comments obtained as a result of this announcement and meeting, we will consider whether additional steps are necessary.

The second major initiative in our overall strategy of DSHEA implementation recognizes the need to ensure product quality and to establish industry-wide standards. In March 2003, FDA proposed a rule on current good manufacturing practice requirements (cGMP) for dietary supplements. The purpose of this proposed rule is to help ensure that dietary supplements are manufactured consistently with respect to identity, purity, quality, strength, and composition.

We are currently reviewing and evaluating more than 1,600 pages of comments, and publication of the dietary supplement cGMP final rule is one of the agency's highest priorities. We greatly appreciated CRN's role in organizing and coordinating comments from the industry to highlight industry agreement on key points.

The third major initiative under our overall implementation strategy for DSHEA will center around protecting consumers against dietary supplement manufacturers who make false or misleading claims, including unsubstantiated claims for their products. We will also continue to monitor and evaluate dietary supplement labeling, including labeling claims and accompanying literature such as flyers, brochures, and catalogs; and will take enforcement action against products whose labeling fails to reveal material facts such as interactions with prescription drugs.

As you know, DSHEA created a category of statements that may be made for dietary supplements. These statements fall into three general categories; nutrient deficiency claims, structure/function claims, and general well-being claims. DSHEA also requires dietary supplement manufacturers to have substantiation for label claims to prove they are truthful and not misleading, but did not define what constitutes substantiation. As a part of this initiative to protect consumers from false or misleading claims, the agency expects to publish a draft guidance in the next few weeks that is intended to describe the amount, type, and quality of evidence a manufacturer should have to substantiate the claim under the Federal Food, Drug, and Cosmetic Act.

In developing this guidance we reviewed existing regulations, case law, Federal Trade Commission experience with its policy on substantiating claims made for dietary supplements in advertising, as well as recommendations from the Commission on Dietary Supplement Labels.

Based on our review of all this information, FDA expects the draft guidance to articulate a substantiation standard of "competent and reliable scientific evidence". This standard is consistent with the FTC standard for advertising.

So, what might this mean? In establishing whether a manufacturer's information would constitute "competent and reliable scientific evidence" the draft guidance is expected to describe a number of factors, including: whether the studies used actually relate to the specific claim being made; the strengths and weaknesses of the studies; if there are multiple studies, are the results similar; and does the totality of the evidence agree with the claim.

The draft guidance is expected to provide flexibility in the precise amount and type of evidence that constitutes substantiation. The guidance is not expected to provide a general rule for how many studies, or what combination of types of evidence, is sufficient to support a claim. Rather, it is expected to describe how, generally, the replication of research results in independently conducted studies adds to the persuasiveness of the evidence, and that ideally, the evidence used to substantiate a claim agrees with the surrounding body of evidence, because conflicting or inconsistent results raise serious questions as to whether a particular claim is substantiated.

The guidance is expected to recommend that dietary supplement manufacturers keep in mind that competent and reliable scientific evidence generally consists of information derived primarily from human studies, either intervention studies or observational studies, and that the gold standard for evidence is the randomized, double blind, parallel group, placebo controlled study.

The draft guidance, when it is published, is expected to contain examples to further explain the concepts described for ensuring that claims are substantiated. We believe that the draft guidance will allow manufacturers to provide truthful information to consumers about the benefits of dietary supplements. We also believe that providing a standard for substantiation may help to preserve consumer confidence in these products.

The final piece in our overall implementation strategy for DSHEA is compliance and enforcement. Let me emphasize that FDA does not anticipate any immediate changes to its enforcement process, we will continue to exercise due diligence in our enforcement activities. FDA is absolutely committed to protecting consumers from misleading claims and unsafe products.

We believe that in general, most of the dietary supplements already on the market are safe. However, unlike most foods, some dietary supplements may contain ingredients that may be pharmacologically active, and we have become increasingly aware of the potential health problems some of these products pose. FDA is committed to taking enforcement action against unsafe products – as evidenced most notably by our actions this year on ephedra and the more recent "andro" action.

We intend to rigorously and vigorously continue enforcement activities and to work collaboratively with federal and other partners to develop the scientific evidentiary base that FDA will use to make safety and enforcement decisions. Our Federal partners include the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative Medicine, and the National Toxicology Program in the Department of Health and Human Services. We are also partnering with the University of Mississippi's National Center for Natural Products Research and FDA's own National Center for Toxicological Research, as well as others.

Our process of enforcement will begin with "signal detection", or identifying an issue of concern. Signals of possible safety concerns may come from Federal, state and local counterparts, adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. In other words we will be monitoring a variety of sources for any early indications of potential problems with a product or ingredient.

When the quality or quantity of these signals indicates that there may be a public health concern, FDA may then seek input from a third party review. Any FDA regulatory action will be based on the totality of the scientific evidence available, this evidence may include the pharmacology of the substance, the scientific literature, adverse event reports and evidence-based reviews. We also want to encourage manufacturers of dietary supplements to report adverse events.

We would then have a variety of options for pursuing our public health mission; including determining unreasonable risk, issuing public health advisories, educating consumers, conducting research, and requiring label changes.

FDA will target those products that pose the greatest risk to consumers by obtaining and analyzing samples of dietary supplements in the marketplace to verify that contents are consistent with labeling, and reviewing Supplement Facts panels to determine whether the substances listed as ingredients can be lawfully marketed in dietary supplements. Obviously, major enforcement initiatives would likely be developed following public discussions of the new dietary ingredient provisions. However, FDA will take immediate action if a dietary ingredient poses a safety hazard as we did with the recent ephedra and adrostenedione actions.

We feel that this process will give consumers access to reliable information about the safety of dietary supplement ingredients and products so they may make informed choices.

Because FDA's primary mission is to protect the public health and FDA shares the mutual goal of consumer protection with FTC, FDA and FTC formed a Dietary Supplement Enforcement Group to closely coordinate our enforcement efforts against health care fraud. As a part of its effort to curb Internet health fraud, FDA has conducted several "surfs" to identify fraudulent marketing of health care products, including dietary supplements, over the Internet. Just this past Friday (10/22) we sent nine warning letters to dietary supplement manufacturers/distributors for unsubstantiated claims on dietary supplement products promoted for weight loss over the Internet. Because these claims lacked substantiation, they were considered false or misleading, and therefore the products were misbranded.

Our strategy for enforcement, which includes cooperation with the FTC and other federal, state, and international organizations, targets adulterated substances such as ephedra, and products marketed as dietary supplements making claims for treatment of serious diseases such as cancer and diabetes.

Some high-profile recent enforcement accomplishments include the final rule prohibiting the sale of dietary supplements that contain ephedra, which went into effect in April 2004; the permanent injunction granted to FDA by the U.S. District Court against Lane Labs-USA, Inc. to prohibit the marketing of three dietary supplement products that were deemed to be unapproved new drugs; and the eight-count indictment obtained by the District Attorney for the Southern District of California against MetaboLife International, Inc and its founder Michael J. Ellis for making fictitious and fraudulent representations to FDA and corruptly endeavoring to obstruct and impede proceedings concerning the regulation of dietary supplements containing ephedra.

With respect to new dietary ingredients, we will bring enforcement actions against marketed dietary supplements that contain new dietary ingredients for which a required pre-market notification has not been submitted; and we will continue enforcement actions against marketed dietary supplements that contain a new dietary ingredient and are adulterated because there is no history of use or other evidence to establish a reasonable expectation of safety.

As you know, after determining that products containing androstenedione posed significant health risks, and had not filed New Dietary Ingredient notification, FDA sent warning letters to 23 companies in March of this year asking them to cease distribution of products sold as dietary supplements that contained adrostenedione and warning them that they could face further enforcement actions if they did not take appropriate measures.

Taken all together, I believe that the overall implementation strategy for the Dietary Supplement Health and Education Act that I have shared with you for the first time today is one that will go a long way, not just in satisfying the intent of the legislation, but in assuring consumers of the safety of the dietary supplements available in the marketplace and the truthfulness of their claims.

At the core of FDA's efforts is its commitment to enhance the legitimate manufacture, sale, and use of dietary supplements while maintaining a zero-tolerance for fraudulent product claims and other illegal practices.

By taking action against dietary supplement products that have false and misleading claims or are misbranded or adulterated we are also helping to maintain consumer confidence in you, the reputable manufacturers of dietary supplements.